Status:
RECRUITING
Aha BOOST Arm-hand BOOST Therapy to Enhance Recovery After Stroke: Clinical, Health Economic and Process Evaluation
Lead Sponsor:
KU Leuven
Collaborating Sponsors:
Vrije Universiteit Brussel
Jessa Hospital
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The overall aim of this study is to establish the clinical- and cost-effectiveness of the arm-hand BOOST therapy when delivered on top of the usual care program in the sub-acute phase post stroke and ...
Detailed Description
Data collection and transfer: * Data will be collected by the clinical sites and by the external researchers from the KU Leuven, VUB and Jessa Hospital. Source documents will be used to collect the d...
Eligibility Criteria
Inclusion
- Maximally 5 months after a first-ever unilateral, supra-tentorial stroke
- Minimally 18 years old
- A residual inpatient stay of minimally 4 weeks
- The ability to sit independently
- Motor impairment in the upper limb, as defined, based on the JSU diagram, as a score of 8-17 on stage 2 (synergies) of the Fugl-Meyer assessment upper extremity (FMA-UE) or a score of \<8 on stage 2 of the FMA-UE, combined with a score of \>6 on stage 5 (hand) of the FMA-UE.
Exclusion
- Severe communication deficits as defined as a score of \<24 out of 32 on the 'visual sentence comprehension' subscale of the Comprehensive Aphasia Test.
- Severe cognitive deficits as defined as a score of \<18 out of 30 on the Montreal Cognitive Assessment.
Key Trial Info
Start Date :
June 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06517251
Start Date
June 17 2024
End Date
April 1 2027
Last Update
July 26 2024
Active Locations (2)
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1
Revalidatieziekenhuis RevArte
Edegem, Antwerpen, Belgium, 2650
2
Revalidatiecentrum K7 UZ Gent
Ghent, Oost-Vlaanderen, Belgium, 9000